Freelance opportunity in Estonia! Interested to join our Clinical Operations team as a Start Up Associate (SSU) with regulatory and start up experience in Estonia for 0.3 FTE?
Start Up Associate is responsible for managing study start-up activities at country and sites’ levels under CTR via CTIS for Part 2 and as per other applicable country regulatory requirements and is accountable for the start-up country and site levels study start-up deliverables.
This is a position for the experienced Study Start-up Associate (SUA) in Estonia within Biomapas Clinical Operations team.
You have energy and motivation to work in a highly motivated and dedicated CO and SSU teams and to gain more experience?
Submit your CV in the English language for consideration.
Responsibilities:
- Perform and manage start-up activities for the assigned studies at country and site levels.
- Prepare, submit, and track initial applications and amendments to Competent Authorities and Ethics Committees (CA/CEC/LEC) /IRBs and other bodies if applicable.
- Manage official communication with Competent Authorities and Ethics Committees (CA/CEC/LEC) /IRBs and other bodies if applicable, prepare RFIs submissions packages to address authorities queries.
- Advise study teams on local legislation from submission perspective, on import/export requirements;
- Adapt trial materials (ICFs, labels, patient documents etc.) to meet local country requirements.
- Compile IP release/Essential documents packages to ensure timely sites activation.
- Support contract negotiations (CTAs) with sites/institutions.
- Manage translation request and translations review of required for submissions local-language trial documentation.
- Keep study management databases updated and file trial correspondence into the TMF as per SOPs and study plans.
- Maintain ongoing status updates with study teams, sites, study PM team.
Requirements
- Bachelor’s degree in Life Sciences, Nursing, or related field.
- Fluent English language.
- Minimum 2-3 years of recent actual experience with Start up activities in Estonia managing submission under CTR via CTIS.
- Strong knowledge in clinical research regulatory requirements at country and global levels as per GCP.
- Experienced user of Microsoft Office Suite.
- Attention to detail and time-management skills.
- Teamwork and collaboration within study teams as well as Clients/vendors as applicable.